Hire the Best Regulatory Affairs Specialist in Chennai, India

Responsible to ensure the Product compliance as per medical device regulation US FDA, EU MDR and IMDR. To ensure timely Product Registration as planned. Expertise in EU MDR & ISO 14155 (Clinical Investigation)& ISO 15223 (Medical Device Symbols for Labeling). Worked on Multiple FDA Submissions and CE mark. Responsible to develop Technical file for CE marking as both MDD & EU MDR, DMR for USFDA - Traditional & Special 510(K) Submissions, etc and documentation for worldwide product registrations. Experienced in USFDA, QSR - Quality System Requirements according to 21 CFR 820, PMS - 21 CFR 822, Medical Device Reporting - 21 CFR 803 & 806 Experienced in CE marking as per MDD & EU MDR for Active Medical device. Responsible for handling Management Representative periodic Internal / External Audits as per ISO 9001, ISO 13485, and product based regulatory audits from FDA and CE - notified body. Have work experience in cross function area - Quality Control, Procurement, Production. Responsible to support & guide the team for new product development. Responsible to collect data from PMS for new improvements. Responsible for Document Control and Records.

I have experience with medical device regulatory domain and quality management. ISO 13485, ISO 14971 Risk management, FDA, DHF, MDR Remediation. Experienced in biocompatibility, Material analysis, technical documentation, Clinical Evaluation, Post Market surveillance. Experienced in Design History file, Worked for US and Europe medical device regulatory bodies.

Regulatory Affairs Engineer with experience and skills of Medical Device Technical File Remediation, Notify Body Submission and Managing Notify Body response for EU MDR 2017/745. Knowledge in MDD and DHF Remediation. Preparation of Risk Management File as per ISO 14971. Also works on CER writing, PMSR/PSUR and SSCP Reports.

Responsible to ensure the Product compliance as per medical device regulation worldwide. To ensure timely Product Registration as planned. Expertise in EU MDR, Clinical Evaluation as per MEDDEV guidance, MDR & as per ISO 14155, Labeling. Worked on Multiple FDA Submissions including De Novo, Pre subs and CE mark. Responsible to develop Tech file for CE marking as both MDD & EU MDR, DMR for USFDA - Traditional & Special 510(K) Submissions, De Novo Submission, Pre-Sub etc and documentation for worldwide product registrations. Experienced in USFDA, CRDH - Quality System Requirements according to 21 CFR 820, PMS - 21 CFR 822, Medical Device Reporting - 21 CFR 803 & 806 FDA Form 483 Inspectional Observation. Experienced in CE marking as per MDD & EU MDR for Active Medical device, stand-alone CDS software and Interacting with the Notified Body. Responsible for handling Design and Development & Management Representative periodic Internal / External Audits as per ISO 9001, ISO 13485, and product based regulatory audits from FDA and CE - notified body. Have work experience in cross function area - Quality Control, Procurement, Production, Supply Chain. Responsible to support & guide the team for new product development. Responsible to collect data from PMS for new improvements. Responsible to conduct MRM Responsible to do Process Validation and writing Validation Protocol & Report for the product development and testing equipment in line with 21 CFR 820 and ISO 13485. Responsible for Document Control and Records.

Senior Professional with extensive experience in managing projects related to Medical Devices. Proficient in EU MDR , US FDA and International standards such as ISO 13485 QMS , ISO 14971, ISO 10993, IEC 60601 and IEC 62366. Certified in EUMDR CE marking and ISO 13485 lead auditor in BSI academy.

Accomplished Senior Regulatory Associate II with Five years of experience, a solid history of achievement and an extensive list of skills acquired over the years. Experienced in supporting a very wide portfolio of pharmaceutical products for all the markets. Track record of achieving exceptional results in supporting the launch of new products to market and in the life-cycle management of on-market products.

Experienced in Regulatory Strategy and execution, Quality Management and Regulatory Intelligence across diverse medical devices (Class I, Class IIa & IIb) for US, EU and Global markets. Diverse product experience - Image Guided Navigation Systems, Digital Health (AI/ML based Medical Device) & SaMD's, Combination products, Drug Delivery devices for US, EU, India-sub continent and Global markets. • Proven leadership in developing and executing global regulatory strategic plans for new product development and lifecycle management. • Managed complex regulatory submissions to achieve product registration, notified body & health authority interactions and audits • Proven success in 510(k) Clearances, CE Certifications, Country specific registrations etc • 7+ years of experience in Medical Devices Industry. • Experienced in leading regulatory affairs for innovative projects working in Research & Development, Software development, AI Algorithm development, Data management, and manufacturing. • Excellent working knowledge of EU MDR, FDA law, and other regulations. • Experienced in preparing STED, GSPR & DoC, Post Market Surveillance Plans and Post Market Clinical Follow-up plans and report • Provide regulatory and scientific review of marketing and labeling materials. • Certified ISO 13485:2016 Internal Auditor. • Extremely passionate and knowledgeable about novel technologies, regulations & guidelines.

Accomplished and results-oriented Regulatory Affairs lead with 10 years of progressive experience in registration and management of New products, Medical devices and different technology to support geographical expansion. Known for learning agility and expert proficiency in Regulatory Affairs and Regulatory Compliance and for building a high functioning regulatory team.